NICardipine for Fast Achievement of Systolic BP Targets in ICH
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nicardipine, Glyceryl trinitrate.
- Who it may be relevant to
- Registry conditions: Intracerebral Haemorrhage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
NICardipine for Fast Achievement of Systolic BP Targets in ICH - a Quasi-randomized, Implementation Trial With Stepwise Rollout of Nicardipin Based Treatment of Hypertension.
Overview
Quality improvement study with a quasi-randomized design. The study monitors the effect of a gradually implemented treatment algorithm prioritizing intravenous antihypertensives (e.g., nicardipine) over long-acting nitrate patches. It aims to increase the proportion of patients reaching target systolic BP \<140 mmHg within 1 hour of hospital admission while monitoring safety, clinical outcomes, and healthcare resource utilization.
Detailed description
Spontaneous intracerebral hemorrhage (ICH) is one of the most time-critical neurological emergencies. Rapid lowering of systolic blood pressure to below 140 mmHg (but not below 110 mmHg) has been associated with reduced risk of hematoma expansion and improved long-term functional outcomes. International guidelines recommend that the target blood pressure be achieved within 1 hour of hospital admission.
Traditionally, the specific class of antihypertensive agent used for acute blood pressure management in ICH was considered less important than achieving the target level. However, emerging evidence from two randomized clinical trials has raised concerns regarding the safety of transdermal long-acting nitrate patches (such as glyceryl trinitrate) in the hyperacute phase of stroke. These studies reported signals suggesting potential harm when nitrate patches were used in the early hours after symptom onset. Further, the time from derug administration to blood-pressure control is longer than intravenous administration.
In contrast, intravenous calcium channel blockers such as nicardipine have demonstrated both efficacy and safety in achieving rapid blood pressure control in acute ICH. These agents are widely used in clinical practice and are recommended in national and international guidelines.
In our institution, the standard protocol for acute blood pressure management in ICH has historically included transdermal glyceryl trinitrate patches. In light of emerging safety concerns and new recommendations, we aim to gradually implement a revised protocol centered on intravenous nicardipine. The implementation will be conducted in a cluster randomized stepwise fashion and monitored closely for its effects on blood-pressure control, safety, workflow, and resource utilization.
Interventions
- Combination product Nicardipine
Nicardipine infusion based acute blood pressure lowering treatment - Combination product Glyceryl trinitrate
Glyceryltrinitrate based acute blood pressure lowering treatment
Primary outcome measures
- Target blood pressure < 140 mmHg 1 hour after admission. [Time frame: 1 hour after stroke center admission]
Secondary outcome measures (12)
- Functional outcome at 3 months [Time frame: 90 days (+/- 14 days)]
- Bed day use [Time frame: 0 to 180 days]
- Total bed day use [Time frame: 0 to 180 days]
- Serious adverse events [Time frame: 90 days]
- Hypotension [Time frame: 0 to 90 days]
- Acute kidney injury [Time frame: 0 to 90 days]
- Reduced level of consciousness [Time frame: 0 to 90 days]
- Intensive care unit [Time frame: 0 to 90 days]
- Neurosurgery [Time frame: 0 to 90 days]
- Mortality [Time frame: 90 days (+/- 14 days)]
- Mortality [Time frame: 180 days (+/- 14 days)]
- Systolic bloodpressure at 1 hour [Time frame: 1 hour]
Eligibility criteria
Inclusion criteria
- Age ≥18 years
- Acute spontaneous Intracerberal Hemorrhage confirmed by imaging
- Symptom onset to stroke center admission <6 hours
- Elevated systolic blood pressure (>140 mmHg) at admission
Exclusion criteria
- Secondary causes of ICH (e.g., trauma, vascular malformation)
- Presumed fatal bleeding at admission
- Short remaining life expectancy (<12 month)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Aarhus University Hospital — Aarhus
Identifiers
NCT: NCT07044232 · NICFAST